[Factor VIII concentrate, highly purified and heated in solution (author's transl)].
A process is described to produce a highly purified factor VIII concentrate heated in solution. Pooled cryoprecipitate from citrated plasma is adsorbed on aluminum hydroxide gel. The fibrinogen is removed by heat denaturation in the presence of glycine; factor VIII is precipitated with sodium chloride from the supernatant. The precipitate is dissolved in a saccharose/glycine solution and heated at 60 degrees C for 10 h. The factor VIII is then separated by further precipitation with sodium chloride, the precipitate dissolved, dialysed and sterilized by filtration. The factor VIII concentrate contains approximately 6 units F VIII:C per mg protein. the ratio of F VIII R:Ag/F VIII:C is 3. The product is free from coagulable protein and gamma-globulins. The efficacy of the heating step in the reduction of the hepatitis B-infectious titre was proved in chimpanzees. For this purpose, hepatitis B virus was added to the pooled cryoprecipitate.
D004355:Drug Stability; D005169:Factor VIII / Q000302:isolation & purification*; D005374:Filtration; D006510:Hepatitis B Antibodies / Q000302:isolation & purification; D006358:Hot Temperature; D006801:Humans
D006510:Hepatitis B Antibodies; D005169:Factor VIII
Faktor VIII-Konzentrat, hochgereinigt und in Lösung erhitzt